Intubation Complication, Muscle Relaxation
Conditions
Keywords
Endotracheal intubation, muscle relaxants, inhalational anesthesia
Brief summary
Prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.
Detailed description
This is a prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain, with the previous approval by the institutional clinical research ethics committee. A total of 91 subjects who underwent general, gastrointestinal, orthopedic, urology and neurological surgery were randomly selected and provided written informed consent before any study-related procedures were performed. The aim of this study was to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.
Interventions
OTHERAvoidance of rocuronium/cisatracurium
Anesthesia induction was performed at tidal volume, avoiding the use of analgesics and/or muscle relaxants with FGF of 6 L/min. Induction time was shortened as the FGF was increased. Once 5% sevoflurane end-tidal volume was reached, ventilation with facial mask was maintained for three more minutes. The time lapsed until the loss of blink reflex was achieved and orotracheal tube (OTT) was placed, difficulties in OTT placement, sevoflurane end-tidal volume after OTT placement, complications related to OTT insertion (movement, coughing, rigidity, apnea), mean arterial pressure (MAP) variations were measured. No muscle relaxants were given during surgery.
DRUGSevoflurane 8% + Intravenous fentanyl
Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female patients * Age ≥ 18 years * ASA ≤ 3 * Able to provide informed consent
Exclusion criteria
* Subjects with left ventricle ejection fraction (LEVF) ≤ 35% * History of ischemic heart disease in the last year * History of malignant hyperthermia * Presence of thoracic drain tubes * Increased intracranial pressure (ICP) or brain tumors, undergoing neurophysiological monitoring * Hemodynamic instability or likely to become unstable during induction of anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events during intubation | Time from anesthesia induction to 12 hours after the end of surgery | Measurement of time lapsed from the loss of blink reflex after anesthesia induction and endotracheal tube placement. Number of patients with difficulty for intubation and number of patients with mean arterial pressure variations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject satisfaction following surgery | from the end of surgery until the discharge day up to 7 days | subjects opinion regarding surgery satisfaction was collected |
| Post operative nausea and vomiting | first 12 hours after surgery | record of nausea and/or vomiting events |
Countries
Spain
Outcome results
None listed